Participant Information Sheet

We would like to ask for your help with a research study that Child Bereavement UK are involved in. Thank you for taking the time to consider helping us. We know that this is a distressing subject. The study is about autopsy and whether there are alternative methods of autopsy that would be considered more acceptable to parents. The aim is to improve the kind of experience parents have when their baby or child dies, particularly if an autopsy is ordered by a coroner.

Before you decide we’d like to explain why the research is being done and what it will involve. Please take time to read the information carefully and ask if there is anything that is not clear. There is no pressure to become involved so take time to decide whether or not you wish to take part. You can also take a look at the Great Ormond Street Hospital website for further information:

http://www.gosh.nhs.uk/research-and-innovation/taking-part-research-0/ongoing-studies/personalising-examination-after-death-improve-experience-bereaved-parents

What is the purpose of the study?
Following the loss of a baby or child, parents may be approached about an autopsy (‘post mortem examination’). This is to find out why it happened and whether there is information that might be important for other family members or future children. In certain cases an autopsy may be required by the coroner to establish the cause of death.

We understand that some parents are reluctant to have an autopsy. In recent years, a number of new ways of performing autopsy which are less-invasive have been developed. For example, a new method which involves a scan called an MRI has been shown to provide highly detailed information. The aim of this study is to understand what parents think of these new methods and whether they would be preferable to current standard methods of autopsy.

Why am I being invited to take part?
We are inviting you because you have sought information, guidance or support from Child Bereavement UK. In addition, you may have personal experience of autopsy. It is important for us to hear from members of the public about this topic so that we can ensure their views and preferences are taken into account when developing services. It does not matter for this study whether you have ever been approached about autopsy or whether one was required by law; either way your thoughts are important to us. We would like to hear from fathers as well as mothers.

What does the study involve?
If you agree to take part in this study, we will ask you to complete an online questionnaire. It is short and should take around 10 to 15 minutes to complete. We are also inviting people to take part in a further interview if they wish (either in person or on the telephone) which will take about 30-45 minutes. Participants will be contacted after responding to the questionnaire. Interview participants will be given a £10 gift voucher as a token of appreciation for their time. You do not have to take part in both the questionnaire and interview, but you can if you would like. 


What are the benefits of the study?
Findings from this study will help us to understand whether parents would prefer to be offered less invasive types of autopsy. If this is the case, this could significantly change the way that autopsy is offered in this country. This research will therefore make a difference to parents in the future who have to make difficult decisions about autopsy.

Do I have to take part?
No, you do not have to take part in this study. It is entirely up to you to decide whether or not you want to. We understand this is a very sensitive topic and some people might find it too difficult to discuss, or simply do not want to discuss it with a researcher.  If you agree to take part you can still change your mind and withdraw at any time without giving a reason.

Will my answers affect my healthcare?
The choices you make on this questionnaire will not affect your healthcare in any way.

What do I do if I want to take part?
If you are willing to take part in the study then please complete the questionnaire on the following page. The questionnaire answers will only go back to the research team.

What if I would like to take part in an interview but do not want to complete the questionnaire?
If you would only like to take part in an interview then please just leave your contact details on the last page of the questionnaire so that we can contact you to arrange an interview.

What are the possible disadvantages and risks of taking part?
The questions are all about autopsy, which is of course a sensitive and difficult topic. You may find some of them upsetting or difficult to answer. If at any point you want to stop being part of the study then that is absolutely fine and you can withdraw. 

Will my participation be kept confidential?
Yes, anything that you say during this research will be kept strictly confidential. Interviews will be audio recorded but your name will not be included in the transcript and any identifying features will be removed. Your name and address will only be stored for the time that we need to be in contact with you and this will be kept separately from any questionnaire and interview answers. No one will know that you are part of the study unless you tell them. Anonymous quotes may be used in the study write-up. Study data will be kept on a secure NHS server and kept up to 3 years from the end of the study.

What will happen to the results of the research study?

At the end of the study, we will write up the findings in a paper that will be published in a medical journal. We will also summarise the findings on support group websites so patients are kept up-to-date. The findings may also be used to support an application for funding for research into new methods of autopsy or may be used directly to influence the way such deaths are investigated in the future. No information will be published that will allow you as an individual to be identified.
Who is organising and funding the research?
The research team is made up of several healthcare professionals at University College London, Great Ormond Street Hospital London and Leicester Royal Infirmary. The team is led by Neil Sebire, a Professor of Paediatric and Developmental Pathology at Great Ormond Street Hospital; Lyn Chitty, a Professor of Genetics and Fetal Medicine at UCLH and Great Ormond Street Hospital; and Celine Lewis, a social scientist from Great Ormond Street Hospital. The study is funded by the National Institute for Health Research, Health Technology Assessment Programme.  

Who has reviewed the study?
This study has been reviewed and given favourable opinion by the London-Bloomsbury Research Ethics Committee (16/LO/0248) Research Ethics Service Committee.

Where can I get further information or discuss any problems?
If you have any further questions about this study then you can contact either Neil Sebire or Celine Lewis – our contact details are at the end of this information sheet. If you would like to speak to someone external to the study for information or support you can contact one of the support groups listed at the end.

Research team contact details:
Neil Sebire    Tel: 020 7829 8663   Email: Neil.Sebire@gosh.nhs.uk
Celine Lewis  Tel: 020 7829 8653   Email: celine.lewis@ucl.ac.uk

Support group details:

Child Bereavement UK - provides support when a baby or child dies. 
Tel - 0800 02 888 40  Email: support@childbereavementuk.org

The Lullaby Trust – provides special support for anyone bereaved through Sudden Infant Death Syndrome (SIDS)

Tel: 0808 802 6868   Email: support@lullabytrust.org.uk

Antenatal Results and Choices - support around termination for fetal anomaly
Tel: 020 7713 7486    Email: info@arc-uk.org

Sands – Stillbirth and neonatal death charity 
Tel: 020 7436 5881   Email: helpline@uk-sands.org
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